NDC 50222-211 Protopic
Tacrolimus Ointment Topical - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 50222 - Leo Pharma Inc
- 50222-211 - Protopic
Product Packages
NDC Code 50222-211-10
Package Description: 1 TUBE in 1 CARTON / 100 g in 1 TUBE
NDC Code 50222-211-30
Package Description: 1 TUBE in 1 CARTON / 30 g in 1 TUBE
Price per Unit: $9.30953 per GM
NDC Code 50222-211-60
Package Description: 1 TUBE in 1 CARTON / 60 g in 1 TUBE
Price per Unit: $9.21215 per GM
Product Details
What is NDC 50222-211?
What are the uses for Protopic?
What are Protopic Active Ingredients?
- TACROLIMUS 1 mg/g - A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.
Which are Protopic UNII Codes?
The UNII codes for the active ingredients in this product are:
- TACROLIMUS (UNII: WM0HAQ4WNM)
- TACROLIMUS ANHYDROUS (UNII: Y5L2157C4J) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Protopic?
- RxCUI: 284520 - Protopic 0.1 % Topical Ointment
- RxCUI: 284520 - tacrolimus 0.001 MG/MG Topical Ointment [Protopic]
- RxCUI: 284520 - Protopic 0.001 MG/MG Topical Ointment
- RxCUI: 284521 - Protopic 0.03 % Topical Ointment
- RxCUI: 284521 - tacrolimus 0.0003 MG/MG Topical Ointment [Protopic]
Which are the Pharmacologic Classes for Protopic?
* Please review the disclaimer below.
Patient Education
Tacrolimus Topical
Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".